BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    UTERINE SOUND

    K Number: K840380 · Decision Apr 30, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    9
    Applicant Total
    5
    Review Days
    91

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    UTERINE SOUND
    K Number
    K840380
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Intl. Medical Technologies, Inc.
    Date Received
    January 30, 1984
    Decision Date
    April 30, 1984
    Product Code
    HHM
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HHM Sound, Uterine

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HHM), ordered by most recent decision date.

    CERVILENZ UTERINE MEASURING SOUND

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    INTRAUTERINE SOUND

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    ROCKET INTRAUTERINE DEPTH SOUND

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    ROCKET INTRAUTERINE SOUND

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    TEFLON UTERINE SOUND

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    AUGROS HYSTEROMETER

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology
    View all

    Other Clearances by Intl. Medical Technologies, Inc.

    K Number Device Name
    K840381 TAPERED CERVICAL DILATOR
    K840382 VACUUM ASPIRATION CATHETER
    K840384 DIAGNOSTIC DILATATION & MENSTRUAL KIT
    K840383 MENSTRUAL ASPIRATION KIT